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Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter (ECLIPSE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Prodimed SAS.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602133
First Posted: May 18, 2012
Last Update Posted: October 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prodimed SAS
  Purpose
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.

Condition Intervention
Venous Puncture Procedure: peripheral venous puncture

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter

Resource links provided by NLM:


Further study details as provided by Prodimed SAS:

Primary Outcome Measures:
  • length of use of the catheter measured in number of days [ Time Frame: seven days ]

Secondary Outcome Measures:
  • adverse event during the period of use of the catheter [ Time Frame: seven days ]
    extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)


Estimated Enrollment: 29
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one intervention arm Procedure: peripheral venous puncture
Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients with need of an intravenous therapy on peripheral line
  • Unsuccessful attempts at establishing a peripheral intravenous line by nurse
  • Age over 18 YO
  • Written informed consent obtained

Exclusion Criteria:

  • pregnant woman
  • local contra-indication for venous puncture
  • unconscious patient
  • need of intravenous therapy requiring central line
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602133


Contacts
Contact: pascal meyer, MD pas.meyer@yahoo.fr

Locations
France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-essonnes, France, 91 100
Sponsors and Collaborators
Prodimed SAS
Investigators
Principal Investigator: Pascal Meyer, MD Centre Hospitalier Sud Francilien- Corbeil- France
  More Information

Responsible Party: Prodimed SAS
ClinicalTrials.gov Identifier: NCT01602133     History of Changes
Other Study ID Numbers: 2011-A01570-41
First Submitted: May 17, 2012
First Posted: May 18, 2012
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by Prodimed SAS:
venous puncture
seldinger technique
ultrasound guidance